Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial

Contemp Clin Trials. 2015 Jul:43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19.

Abstract

Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.

Trial registration: ClinicalTrials.gov NCT02246413.

Keywords: Depression; Lifestyle change; Obesity; Problem solving therapy; Randomized controlled trial; Standard behavioral treatment.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Affect
  • Age Factors
  • Antidepressive Agents / administration & dosage
  • Antidepressive Agents / therapeutic use*
  • Behavior Therapy / economics
  • Behavior Therapy / methods*
  • Body Mass Index
  • Body Weight
  • Combined Modality Therapy
  • Cost-Benefit Analysis
  • Depressive Disorder / epidemiology
  • Depressive Disorder / therapy*
  • Female
  • Humans
  • Male
  • Obesity / epidemiology
  • Obesity / therapy*
  • Primary Health Care / organization & administration
  • Racial Groups
  • Research Design*
  • Sex Factors
  • Socioeconomic Factors

Substances

  • Antidepressive Agents

Associated data

  • ClinicalTrials.gov/NCT02246413